MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLND SKID

Catalog Number 315-03-01

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during a initial shoulder procedure on a (b)(6) female, the surgeon reduced shoulder to trial selected implants, utilized skid to dislocate trials, and skid snapped.Patient was last known to be in stable condition following the event.The device will return for evaluation.

Manufacturer Narrative

Section h10: (h3) based on previous similar complaint investigations, the broken glenoid skid reported was likely the result of applying a bending moment to one end of the instrument which led to fracture of the device.

• Brand Name: EQUINOXE
• Type of Device: GLND SKID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11373843
• MDR Text Key: 233462491
• Report Number: 1038671-2021-00074
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862084774
• UDI-Public: 10885862084774
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315-03-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR